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Augmedics XVISION-SPINE User Manual Download Page 11

2. Safety Information

This chapter contains important information regarding the safety and performance of the

XVISION

-S

PINE

(

XVS

) system.

Setup and training of the

XVS

system is provided by Augmedics Ltd.

Do not operate the

XVS

system before reading this manual and gaining a clear understanding

of the operation of the system. If any part of this manual is not clear, contact your Augmedics
representative for clarification.

This manual should always accompany the

XVS

system, and its location must be known to all

personnel operating the system. Additional copies of this manual are available from your
manufacturer.

Warning:

Failure to follow the guidelines and instructions provided in this chapter could
result in faulty function of the

XVS

system and cause personal injury or death.

Caution:

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Caution:

Operation of the

XVS

system shall be performed by qualified personnel only.

2.1. Compliance with IEC 60601-1 Standard

The

XVS

system complies with safety standards IEC 60601-1 and AAMI ES60601-1, and is

internally powered ME equipment.

Warning:

Use only batteries provided by the manufacturer.

Warning:

Avoid spilling any liquids on the device. In any case of liquid spill, shut off the
device and notify the manufacturer before using it again.

2-1

Summary of Contents for XVISION-SPINE

Page 1: ...XVISION SPINE User Manual Augmedics Ltd 1 Ha Tsmikha St Yoqneam Illit 2069205 Israel 1 888 814 4988 Version 7 https augmedics com ...

Page 2: ......

Page 3: ...lation into another language Please note that while every effort has been made to ensure that the data given in this document is accurate the information figures illustrations tables specifications and schematics contained herein are subject to change without notice License Contract XVISION SPINE design is the exclusive property of Augmedics Ltd Any copying either in part or in whole is strictly p...

Page 4: ......

Page 5: ...3 Reporting Device Security or Privacy Breaches 2 4 Recovering from Compromised Accounts 2 4 Unavailable Service 2 4 Remaining Current on Cybersecurity Updates 2 4 Software Maintenance Support for the Software 2 5 2 6 Electromagnetic Immunity Declaration 2 5 Headset 2 5 Optional Tablet and Router 2 7 2 7 Method of Sterilization or Disinfection 2 10 2 8 Manufacturer Responsibility 2 10 2 9 General ...

Page 6: ... Surgeon 5 3 5 5 Headset Pairing 5 6 5 6 Configuring the Scanner Imaging Protocol 5 6 5 7 xvision Spine Footswitch Battery Installation 5 8 6 xvision Spine System Preprocess Workflow 6 1 6 1 Starting up the xvision Spine System 6 1 6 2 Prepare Surgical Tools 6 4 Universal Tool Adaptors 6 5 Navigated Tool Adaptors 6 6 VP Tool Adaptors 6 7 6 3 Surgical Instrument Calibration 6 8 6 4 Screwdriver Cali...

Page 7: ...Appendix A System Specifications A 1 Appendix B Waste Electrical and Electronic Equipment B 1 Appendix C XVS Tool Adaptors C 1 Appendix D XVS Patient Clamps C 1 Appendix E Setting up the Medtronic O arm 2 Scanner D 1 E 1 Connecting Ethernet Cable to xvision Spine D 1 E 2 Setting IP Address D 1 E 3 Imaging Settings D 2 E 4 Sending Image to xvision Spine D 3 Appendix F Setting up the Medtronic O arm...

Page 8: ... G 1 H 2 Setting IP address G 1 H 3 Imaging Settings G 2 H 4 Sending Image to xvision Spine G 3 Appendix I Setting up the Siemens Cios Spin Scanner H 1 I 1 Connecting Ethernet Cable to xvision Spine H 1 I 2 Setting IP Address H 1 I 3 Imaging Settings H 3 I 4 Sending Image to xvision Spine H 4 Appendix J All In One Computer User Manual I 1 Appendix K Tablet Computer User Guide J 1 viii ...

Page 9: ... covered by one or more patents or patent applications available at https augmedics com patents 1 2 Conventions Used in this Manual Throughout this manual cautions and warnings are used to provide critical information needed before the device is used Warning Alerts the user to the possibility of injury death or other serious adverse reactions associated with the use or misuse of the system Caution...

Page 10: ...rt number Batch code Sterilized using irradiation oxide Indicate that the component needs to be sterilized but has not yet been through the sterilization process Prescription only U S federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner Dispose of used material as per the Waste Electrical and Electronic Equipment Directive WEEE requirements ...

Page 11: ... of this manual are available from your manufacturer Warning Failure to follow the guidelines and instructions provided in this chapter could result in faulty function of the XVS system and cause personal injury or death Caution Federal law U S A restricts this device to sale by or on the order of a physician Caution Operation of the XVS system shall be performed by qualified personnel only 2 1 Co...

Page 12: ...ennas should be used no closer than 30 cm 12 inches to any part of the XVISION SPINE system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Caution Any changes or modifications not expressly approved by Augmedics Ltd could void the user s authority to operate the equipment 2 4 1 FCC Class A This device complies with part 15 of ...

Page 13: ...ospital PC Security It is the responsibility of the authorized user to ensure that the hospital PC on which the XVISION SPINE application is installed is not left unattended unlocked or otherwise unsecured when not in use to ensure that non authorized medical professional or otherwise unapproved personnel are not exposed to or gain access to ePHI The same applies to the pre configured Augmedics PC...

Page 14: ...nfigured Augmedics PC If the XVISION SPINE cybersecurity has been compromised and any changes have been made to the XVS SOFTWARE the software will detect this and prevent running This event is logged to the system log file Recovering from Compromised Accounts If the XVISION SPINE cybersecurity has been compromised and any changes have been made to the XVS SOFTWARE the software will detect this and...

Page 15: ...s B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment HEADSET Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group1 Class A The XVS system and the Tablet use RF energy only for its internal function Th...

Page 16: ...P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range D Interference may occur in the vicinity of equipment marked with the followin...

Page 17: ...e wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment 1 kV for input output lines 1 kV for input output lines Surge IEC 61000 4 5 1 kV line s to li...

Page 18: ...ower rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range D Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC ...

Page 19: ... a MHz Servicea Modulationb Maximum Power W Distance m Immunity Test Level V m Compliance Level V m 385 380 390 TETRA 400 Pulse modulationb 18 Hz 1 8 0 3 27 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 28 710 704 787 LTE Band 13 17 Pulse modulationb 217 Hz 0 2 0 3 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulationb 18 Hz 2 0 3 28...

Page 20: ...rt Immunity to RF Wireless Communications Equipment Headset and Optional Tablet continued 2 7 Method of Sterilization or Disinfection The sterile components of the XVS system are supplied gamma radiation sterilized and are intended for single use only See Cleaning Reusable Components on page 8 1 and Steam Sterilization page 8 3 for information on cleaning and sterilization of reusable components o...

Page 21: ...ved to verify that they are operating normally Warning Do not use the HEADSET if inspection before use reveals any damage such as case damage or loose connectors Contact service Warning The XVISION SPINE system is not intended for diagnostic purposes Caution For continued protection against the risk of fire use only system cables and accessories approved or supplied by Augmedics Other cables and a...

Page 22: ......

Page 23: ...s an adjunct for surgical guidance It is not a replacement for the surgeon s knowledge expertise or judgment 3 1 Intended Use The XVISION SPINE system with the XVISION SPINE SYSTEM SOFTWARE is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures Their use is indicated for any medical condition in which the use of stereotactic surgery may b...

Page 24: ...d xvision Spine User Manual Version 7 3 3 Contraindications Medical conditions which contraindicate the use of the XVS system include any medical conditions which may contraindicate the medical procedure itself 3 2 ...

Page 25: ...ese virtual images are of a 3D model and axial and sagittal 2D views The HEADSET displays the same virtual images with the 3D model aligned with the patient The computer running the XVS SOFTWARE is connected to the HEADSET by WiFi Dedicated menus of the user interface are accessed either with a touch screen or a mouse and keyboard 4 2 Router The router is used to support wireless communication bet...

Page 26: ...EADSET can be powered by either a large or small size battery See System Specifications on page A 1 for more information about the differences between these batteries Recharge the HEADSET battery after every surgical procedure by placing it in its charger stand The full charge cycle takes between one to two hours See Battery and Charger on the facing page for more information The projected display...

Page 27: ... HEADSET Battery for Charging 1 2 3 1 Press the ribbed buttons on either side of the battery Note Both large and small batteries are shown 2 Pull the battery out of the battery case 3 Set the battery into its charger stand Recharge the battery after every surgical procedure The full charge cycle takes between one to two hours Note When the battery reaches 30 life cycles contact Augmedics Ltd 4 3 ...

Page 28: ...ore information Always dispose of spent batteries according to local codes Figure 3 Footswitch AB D C E F G A Power indicator B Connection indicator C Power input D Right pedal Add Remove virtual screw E Center switch Toggle display off and on F Left pedal Toggle 3D Fixed 3D Off G USB receiver module 4 6 Reusable Components Reusable components are provided in a tray that can be used for sterilizat...

Page 29: ...Tools ASP00027 B XVS Arc Clamp AMCH00006 C XVS Short Straight Clamp 62 mm AMCH00005 D XVS Wrench AMCH00030 E Screwdriver 4 mm SCDH00004 F Fixed 3 4 mm universal tool adaptor Leg Up AMCFSU03 G Swivel 7 5 9 mm universal tool adaptor Leg Down AMCRMD75 H XVS VP Adaptor AMC00001 I Fixed 3 4 mm universal tool adaptor Leg Down AMCFSD03 J Z Marker 40 AMCH01040 K Z Marker 60 AMCH01060 4 5 ...

Page 30: ...d Tool Adaptor AMC04180 H XVS VP Adaptor AMC00001 I Fixed 3 4 mm universal tool adaptor Leg Down AMCFSD03 J Z Marker 40 AMCH01040 K Z Marker 60 AMCH01060 4 7 Single Use Sterile Kit A single use sterile kit containing two Patient Markers and six Tool Markers is provided for each surgical procedure All markers within the set are sterile and are intended for single use Each patient marker includes do...

Page 31: ...e If the package is found opened or damaged discard these components and use components from a new package Warning Do not use the contents of more than one Sterile Use Kit in a single procedure Markers with the same ID from different kits may confuse the XVISION SPINE system Figure 6 Single Use Sterile Kit B A A Patient markers 2 B Tool markers 6 4 8 Optional Accessories The following optional acc...

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